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Proglycem (DIAZOXIDE)
Proglycem works by blocking the ATP-sensitive potassium channel, which helps to increase blood sugar levels and reduce insulin secretion.
Proglycem (Diazoxide) is a small molecule diazoxide drug that targets the sulfonylurea receptor 1 (SUR1) and Kir6.2 subunit of the ATP-sensitive potassium channel. Originally developed and currently owned by Teva Branded Pharm, it was FDA-approved in 1973 for various indications including hyperinsulinism, hypertensive emergencies, and insulinoma. As an off-patent medication, Proglycem is available as a generic from multiple manufacturers. Key safety considerations include its potential to cause hypotension and electrolyte imbalances. Proglycem's commercial status allows for generic competition.
At a glance
| Generic name | DIAZOXIDE |
|---|---|
| Sponsor | Teva Branded Pharm |
| Drug class | diazoxide |
| Target | Sulfonylurea receptor 1, Kir6.2 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1973 |
Mechanism of action
Imagine your cells have a special gate that controls how much sugar and insulin they let in. Proglycem blocks this gate, making it harder for insulin to enter the cells and causing blood sugar levels to rise. This can be helpful for people with conditions like hyperinsulinism, where their cells are producing too much insulin.
Approved indications
- Hyperinsulinism
- Hypertensive Emergencies
- Hypertensive urgency
- Insulinoma
- Islet cell hyperplasia
Common side effects
- Hypoglycaemia
- Necrotising colitis
- Hyperglycaemia
- Insulinoma
- Hypertrichosis
- Hyperglycaemic hyperosmolar nonketotic syndrome
- Pancreatectomy
- Drug ineffective for unapproved indication
- Pulmonary hypertension
- Necrotising enterocolitis neonatal
Key clinical trials
- Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome
- Effect of Insulin Lowering on Lipogenesis (PHASE1)
- Glycemic Effect of Diazoxide in NAFLD (PHASE1)
- Diazoxide Suppression Test P&F Study (PHASE1)
- Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF) (PHASE4)
- Safety and Feasibility of Hyperkalemic Cardioplegia With Diazoxide in Cardiac Surgery (CPG-DZX) Trial (PHASE1)
- Use of Functional MRI to Assess Functional Hypothalamic Activation in Response to Diazoxide (PHASE2)
- Central Mechanisms That Regulate Glucose Metabolism in Humans (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Proglycem CI brief — competitive landscape report
- Proglycem updates RSS · CI watch RSS